Tube body sealing and cutting device

Abstract

To provide an improved device capable of sealing and cutting a tube body.SOLUTION: A tube body sealing device 100 includes a sealing iron 1 having a tube body sealing end, and an insulating shroud 2 having a tube body clamping end 14. The sealing iron is arranged in the insulating shroud at least partially. The device also includes an anvil 5 having a cutting detail, and a non-stick membrane 3 arranged between the anvil and the tube body clamping end of the insulating shroud. The sealing iron and the insulating shroud are constituted so as to advance toward the tube body to be sealed which is positioned between the non-stick membrane and the anvil. The tube body clamping end is constituted so as to clamp the tube body via the non-stick membrane. The sealing iron is constituted so as to advance toward the tube body, and to melt and seal the tube body through contact with the cutting detail via the non-stick membrane.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the earlier filing date of U.S. Provisional Application No. 62 / 820,372, filed March 19, 2019, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Embodiments of the present disclosure relate to equipment used in bioprocessing, cell therapy, and regenerative medicine manufacturing. The equipment is designed to automate and control a variety of processes that typically require the use of valves, pumps, and other devices to manipulate and process various media within a functionally closed disposable set. The equipment most commonly operates within clean rooms within drug manufacturing plants.

[0003] For many processes, there is a need to separate tubes to aseptically seal and isolate media, product, QC samples, or simply break down larger, more complex sets into smaller subsets for easy management and preparation for disposable use. Summary of the Invention

[0004] The invention will now be described with reference to the accompanying drawings which show non-limiting examples of embodiments of the invention. [Brief description of the drawings]

[0005] [Figure 1A] 1 is a cross-sectional view of a tube sealing and cutting device in a starting position, according to a non-limiting example of an embodiment. [Figure 1B] 1B is a schematic diagram of the tube sealing and cutting apparatus of FIG. 1A, with the sealing cycle beginning. [Figure 1C] FIG. 1B is the tube sealing and cutting apparatus of FIG. 1A with sealing beginning. [Figure 1D]FIG. 1B is a tube sealing and cutting apparatus of FIG. 1A, where the seal has started to solidify and cut (or the tube has started to thin to a point where it is more likely to separate). [Figure 1E] FIG. 1B is a diagram of the tube sealing and cutting apparatus of FIG. 1A, with sealing and cutting or separation completed; [Diagram 2] FIG. 1 is a schematic diagram of a tube sealing and cutting device for a bag filling application. [Figure 3A] 13 is a cross-sectional view of another exemplary embodiment of a tube sealing and cutting apparatus in a standby / tube loading position with the door in an open position. [Figure 3B] 3B is a cross-sectional view of the tube sealing and cutting device of FIG. 3A in a sealing and cutting position. [Figure 3C] FIG. 3B is a detailed view of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] There are significant advantages and risk reductions that can be realized by automating the sealing and cutting of tubing. The equipment available to perform the sealing and sterile separation operations has a range of disadvantages: · Costly (i.e., expense and / or wear and tear per cut (e.g., sterile separators, clamp sleeves, Clipster™ sterile tube separator system)). - Takes a long time to actuate or apply. · They are dangerous (e.g. clamp sleeve cutters, cutting clamp sleeves often creates sharp corners that may require the application of additional protective cover components). · Requires significant tubing length and / or space around the tubing to operate the device and create a seal to achieve isolation. · If not portable, requires service for non-manual / non-battery powered equipment (AC power, compressed air). · Restrictions on tube material (i.e. only RF (radio frequency) sealers work on tubes containing polar materials e.g. PVC, EVA). · Constraints on tube dimensions (i.e. external shape and wall thickness). Ability to safely and reliably seal fluid-filled tubes (e.g., RF tube sealers will arc when sealing liquid-filled tubes, potentially causing the fluid inside the tube to ground and lead to pinholes in the tube wall).

[0007] Potential advantages of embodiments of the present disclosure, particularly when incorporated into instrument elements, can address several shortcomings of many of the currently available tube sealing and cutting options. Advantages include: A reliable sealing and cutting process that results in consistent sealing and separation of tubes without the need for scissors or other sharp objects, which are often used to separate sealed tubes but pose special risks to the operator regarding potential bio-contamination. · Ability to perform sealing and cutting operations on a variety of tube materials and sizes with slight configuration changes and operating parameters. Relatively quick sealing and cutting cycle times. · Incorporate into the platform the necessary precautions to protect the operator. Tight integration of tube sealing and cutting equipment allowing for the shortest possible tube length, which allows for the most compact and cost effective disposable set, potentially resulting in reduced media loss (i.e. waste) and maximum performance (i.e. precise fluid delivery control / supply). · Automation to minimize operator interaction. · There is no significant cost per seal and cut (as is the case with techniques that use consumables).

[0008] Thus, embodiments of the present disclosure incorporate improved tube sealing and cutting devices into this conventional equipment. These embodiments achieve fast sealing and cutting cycle times, but maintain robust and repeatable sealing and cutting. These embodiments also systematically avoid exposing operators to dangerous heat and destroying tubes, which are risks of some current separation methods and can lead to process leaks and possible production or even batch losses.

[0009] Electrically heated sealing irons are often used to seal tubes made of thermoplastic materials. Typically, the sealing irons have an anti-stick coating to prevent the tube material from adhering to the iron and leaving behind a residue. When such devices are used for tube sealing, they are also manually operated. This requires human operation with dexterity and vision to load and unload the tube, and to peel the tube from the iron if it is slightly stuck to ensure there is no residue or to remove it so as not to adversely affect the subsequent weld. In addition, for the sake of seal integrity and operator safety, current technology is limited to relatively long cycle times (i.e., several minutes) since the unit can only heat, seal, and cool when latched closed.

[0010] Also, embodiments incorporate a cutting detail on the anvil that faces the sealing iron. This feature is used in impulse and RF (radio frequency) sealers used on tubes. The idea is that the tube material melts and flows, thinning the area where it is cut open to ensure that the adjacent surfaces are completely sealed. Thus, the cut or separation point is accomplished aseptically with the inside surface (and contents) of the tube not exposed to the outside surface.

[0011] In the disclosed embodiment, the anvil or seal backup is attached to a door that is hinged out of the way to allow loading of the disposable set, but is then latched closed to precisely establish tube position and anvil placement. Additionally, the door is interlocked to ensure that the operator does not have access to dangerous heating or pinch points, yet the tube sealing and cutting operations can occur.

[0012] The disclosed embodiment comprises: · The tube sealing and cutting operation is carried out by clamping a heated sealing iron against the tube via an anti-stick film which helps to avoid the tube sticking after the cutting and sealing operation. Retracting the sealing irons (after optimal sealing and cutting parameters (i.e. force and temperature) have been achieved) allows for short cycle times, allows operator access without excessive delays due to required manual interaction, and without access / exposure to dangerous heat and pinch points. · Maintains sealing irons at proper temperature without operator access / exposure to dangerous heat and pinch points.

[0013] The membrane is thin and flexible, allowing it to conform and twist to the shape of the sealing iron (and surrounding isolation shroud). The fact that the membrane is non-stick enhances sealing and cutting with appropriate release properties to prevent tubes from sticking and aids in unloading (automatic or manual) following the sealing and cutting cycle. With regards to equipment design and cleanroom installation / operational compatibility, the membrane also serves to isolate heaters and associated actuation and other mechanisms that may otherwise pose clean / clean design challenges. The membrane becomes a surface that the operator faces and must clean and maintain.

[0014] The disclosed embodiments have the iron preheated to a predetermined temperature that quickly transfers through the thin film material to cause the requisite melting, and then retracts the iron after the cut or tube separation is fully established. These aspects provide for relatively quick cycle times that can be routinely achieved, necessary for maximizing productivity benefits, and subsequent consistent, leak-free sealing and cutting performance requirements.

[0015] 1A-1E, a tube sealing apparatus 100 according to an exemplary embodiment of the present disclosure is shown in sequence. The tube sealing apparatus 100 includes a heating block or tube sealing iron 1 translationally disposed within an isolation shroud 2. The sealing iron 1 has a sealing end 12 with a stepped portion at its sealing surface end. The isolation shroud 2 has a tube clamping end 14 with a narrow portion corresponding to the stepped portion of the sealing end 12. A seal backup or anvil 5 is disposed at the tube clamping end 14 of the isolation shroud 2 and is attached to a rigid reaction surface or safety interlock door (not shown in FIGS. 1A-1E) that limits finger access by an operator. The anvil 5 has a small tube cutting detail 16 thereon opposite the tube clamping end 14 of the isolation shroud 2. The cutting detail 16 may be configured as a ridge that provides for thinning of the tube material after a seal is established in this section of the tube. This allows for quick separation of the tube ends by the operator with minimal to zero pulling or peeling force required to cut the newly established sealed tube end without the need for tools or sharp objects and without the risk of destroying the tube seal. The anti-adhesive film 3 is disposed between the tube clamping end 14 of the isolation shroud 2 and the anvil 5. The tube 4 to be sealed is located between the anti-adhesive film 3 and the anvil 5. The isolation shroud 2 is configured to operate in a reciprocating fashion, advancing towards and retracting away from the anvil 5. The sealing iron 1 is configured to operate in a reciprocating fashion, advancing towards and retracting away from the anvil 5, and is also configured to move relative to the isolation shroud 2. The sealing iron 1 and isolation shroud 2 can be reciprocated using a mechanism as described below with reference to Figures 3A-3C.

[0016] 1A-1E illustrate the tube sealing and cutting procedure. Referring to FIG 1A, the isolation shroud 2 and sealing iron 1 are shown in a starting position fully retracted from the anvil 5.

[0017] Referring to FIG. 1B, the start of the sealing cycle is shown as the isolation shroud 2 and sealing iron 1 advance to press the tube 4 through the membrane 3 against the anvil 5 .

[0018] 1C, a further progression of the sealing cycle is shown where the isolation shroud 2 and sealing iron 1 advance further to press the tube 4 through the membrane 3 against the cutting detail 16 on the anvil 5 where material of the tube 4 melts and is sealed with the sealing iron 1 to maintain pressure. Material flows out of the cutting detail 16 as the sealing iron 1 contacts the cutting detail 16 through the membrane 3 and cuts open the tube 4.

[0019] 1D, the seal and cut integration position is shown where the tube material is solidified with the retracted sealing iron 1. In this configuration, the isolation shroud 2 advances and remains clamped to the tube 4 as the tube material solidifies, ensuring that the seal remains established, especially due to the high stiffness of the tube material and the restoring forces that would cause the seal to break or otherwise be compromised during the short solidification period.

[0020] Referring to FIG. 1E, the sealing and cutting completed position is shown where both the isolation shroud 2 and the sealing iron 1 have retracted away from the anvil 5 and where the tube 4 has been sealed and cut or separated into two separate elements, allowing the tube and the connecting elements on the left and right sides of the newly established cutting or separation point to be separated from each other.

[0021] The isolation shroud 2 helps reduce energy usage due to radiation and convection losses. This configuration plays a key role in clamping the tube 4 to provide a temperature gradient that limits the melt boundary within the tube 4, especially for thin-walled and rigid tubes, where restoring forces can lead to stresses at the melt transition that could otherwise cause the tube wall to break. This isolation shroud 2 clamps the tube 4 to break the transition from a flat clamped tube to its natural round state at the high temperature / melt zone. This helps provide the necessary margin for a stronger seal, especially on thin-walled (e.g., 0.5 mm or less) tubes. Additionally, when the sealed tube 4 is filled with liquid, the isolation shroud 2 serves to help impede and push the fluid out of the sealing and high temperature zone, helping to prevent the fluid from being exposed to high temperatures. This reduces excess pressure buildup due to the fluid / evolving gases that could cause possible boiling and rupture of the melted tube wall during the sealing process. Depending on the application, these may be residual or induced tensions on the tube 4. Because the isolation shroud 2 is configured as a clamp, it can also act to isolate the tension and prevent the seal from being compromised by the tube 4 being under tension, which would otherwise quite easily lead to stretching or elongation of the molten section of the tube, leading to destruction of the seal or the tube wall.

[0022] Regarding the integration of this tube sealing device 100, in various configurations, it can be utilized to aid in sealing and cutting different tube materials and wall thicknesses. In bag filling where there are multiple bags in a row, the door can cover all the bags and filled tubes with successive or separate anvils backing up each tube except the cross sealer. In this regard, a single sealer can help provide uniformity in terms of force and temperature for each of the tubes, which has been commonly utilized where multiple service positions significantly reduce the cost and complexity of the equipment control system by avoiding having multiple sealing heads. Also, in bag filling embodiments, the bags are often filled sequentially, with a single cross device means, and the cutting and sealing of the tubes can occur directly following the filling of a bag while the next bag is being filled. In this way, productivity is maximized by avoiding the end sealing and cutting of all the bags. Instead, the present invention allows the bags to be available and removed in a timely manner, allowing subsequent processing to occur sequentially and directly after the tube sealing and cutting process is completed. Referring to FIG. 2, a bag filling application apparatus 18 is shown illustrating the progressive filling of a bag 20 with a tube 4, sealing and cutting with a tube sealing device 100, and subsequent removal of the bag 20.

[0023] 3A-3C, another exemplary embodiment is shown, which incorporates most of the features described in the previous embodiment, in which the iron 1 and shroud 2 move together rather than relative to each other, and their respective sealing and tube clamping ends do not have corresponding narrow features.

[0024] Referring to Figure 3A, the tube sealing and cutting apparatus is shown in a standby position ready for installation / loading of tube 4. The membrane 3 is fixed to a membrane holder on the housing 6 and is a 3" (75mm) wide web or strip of membrane film, clamped to the holder which helps to form / achieve the required convex 2D shape. If required, the membrane holder is removable from the platform for membrane replacement and maintenance.

[0025] A typical example where this sealing and cutting device can be used is a bag that needs to be filled with a required amount of fluid and then aseptically sealed and separated. In this example, a disposable set including the bag and the filling tube can be loaded onto the system, the tube section extending in front of the membrane 3 at the required position will be sealed and cut, then the door 7 will be closed on the tube 4 to bring the anvil 5 into position.

[0026] 3B and 3C, the tube sealing and cutting system is shown in the sealing position. Continuing with the bag filling example, after the bag is filled, the heated sealing iron 1 assembly is actuated forward, forcing the tube 4 through the anti-adhesive membrane 3 against the anvil 5, resulting in the sealing and cutting / separation of the tube 4 as outlined above with respect to FIGS. 1A-1E. The mechanism used to move / actuate the components actively involved in the sealing function can be a pneumatic cylinder and electric actuator, or a guided ball screw actuator including an electric motor assembly 9 that moves the sealing iron 1 assembly carrier 10 as shown. Force control of the ability of the sealing iron assembly to move forward and maintain force during the sealing operation as the tube melts and flows is an important and useful aspect for obtaining repeatability of the system. This can also be achieved using a guided pneumatic cylinder (for pneumatically actuated systems). With respect to the electric actuator, force control can be achieved using torque (i.e. motor current) control, or in another embodiment, using a spring-loaded head with variable position adjustment (i.e. stroke) that controls the force applied during the sealing operation.

[0027] At the end of the sealing cycle, the heated sealing iron 1 assembly retracts rearwardly away from the membrane 3 and anvil 5, allowing for solidification of the molten tube 4 material to complete the sealing and cutting. This sealing process can be repeated multiple times across to allow for the sealing and cutting of multiple adjacent tubes 4. At the end of the process, the door 7 is opened and the filled, sealed and separated bags are removed for further processing (labeling, packaging, freezing, etc.).

[0028] Exemplary operating parameters are given below: Iron Temperature: Operating range = 100°C -> 200°C, typical seal range dependent on tube. Nominal set point = 160°C. Potential high temperature for intermittent operation is 350°C. Iron contact time: Operating range = 6 -> 30 seconds, depending on the tube. Iron pressure / force: Operating range = 80N → 200N. Nominal setting value = 120N.

[0029] The iron 1 may be made of aluminum or other suitable thermally conductive material. The shroud 2 and anvil 5 may be made of polyether ether ketone (PEEK) or other suitable material with high continuous operating temperature capability. The anti-adhesive membrane 3 may be made of PEEK or polyimide film or other suitable material that is suitably thin and flexible so that heat can be easily transferred therethrough from the sealing iron assembly to the tube, yet capable of intermittently withstanding the processing temperatures without degradation.

[0030] Features of the disclosed embodiments can be combined, rearranged, omitted, etc., within the scope of the present invention to produce additional embodiments. Furthermore, in some cases, certain features can be used to advantage without the concomitant use of other features.

[0031] Many alternatives, modifications, and variations are possible with this disclosure. While particular embodiments have been shown and described to illustrate the application of the principles of the invention, it is to be understood that the invention can be embodied without departing from such principles. Accordingly, the applicant intends to embrace all alternatives, modifications, equivalents, and variations that are within the spirit and scope of the invention. [Explanation of symbols]

[0032] 1 Sealing Iron 2. Isolation Shroud 3. Anti-adhesion film 4. Body 5. Anvil 12 Sealed end 14 Tube Clamp End 16 Cutting details 100 Tube sealing device

Claims

1. 1. A tube sealing device for sealing a rigid tube, comprising: a sealing iron including a tube sealing end; an isolation shroud including a tube clamping end and within which the sealing iron is at least partially disposed; an anvil including a cutting detail; an anti-adhesive film disposed between the anvil and the tube clamping end of the isolation shroud; Equipped with the sealing iron and the isolation shroud are configured to advance toward the rigid tube to be sealed, the rigid tube being positioned between the anti-adhesive membrane and the anvil; the tube clamping end is configured to clamp the rigid tube via the anti-adhesive film; the sealing iron is configured to advance towards the rigid tube to melt and seal the rigid tube to the cut detail via the anti-adhesive film; a tube sealing end of the sealing iron that is stepped and a tube clamping end of the isolation shroud that has a narrow portion corresponding to the stepped portion and that is configured to engage with the narrow portion, the sealing iron and the isolation shroud configured to together seal the rigid tube.

2. The tube sealing apparatus of claim 1 , wherein the sealing irons and the isolation shroud are configured to retract away from the anti-adhesive membrane after sealing the rigid tube.

3. 3. The tube sealing apparatus of claim 2, wherein the sealing iron and the isolation shroud are configured to move together when retracting away from and advancing toward the anti-adhesive film.

4. 3. The tube sealing apparatus of claim 2, wherein the sealing iron and the isolation shroud are configured for relative movement when retracting away from and advancing toward the anti-adhesive film.

5. The tube sealing device of claim 2 , wherein the anvil is attached to a door operatively configured to allow loading of the rigid tube between the anvil and the anti-adhesive membrane.

6. The tube sealing device of claim 1 , wherein the cutting details are configured as ridges that cause a thinning of the material of the rigid tube.

7. 2. The tube sealing device of claim 1, wherein the anti-adhesive membrane is constructed from one of polyether ether ketone (PEEK) and polyimide film.

8. 3. The tube sealing apparatus of claim 2, wherein the sealing iron is configured to be at a temperature between 100° C. and 200° C. when advancing towards the anti-adhesive film.

9. 3. The tube sealing device of claim 2, wherein the sealing iron is configured to contact the anti-adhesive film for between 6 and 30 seconds.

10. 3. The tube sealing device of claim 2, wherein the sealing iron is configured to contact the anti-adhesive film with a force between 80N and 200N.

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